| Date Initiated by Firm | April 06, 2023 |
|---|
| Date Posted | June 06, 2023 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1690-2023 |
|---|
| Recall Event ID |
92283 |
| Product Classification |
Gynecological laparoscopic kit - Product Code OHD
|
| Product | Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack.
Convenience kit used for Laparoscopic surgery |
|---|
| Code Information |
Catalog Number: SMA21LPUHJ; Lot Number: 019693 |
| FEI Number |
3001236905
|
Recalling Firm/
Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
|
Manufacturer Reason
for Recall | Inadvertently released for distibution without sterility assurance. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | Cardinal Health initially notified customer on 04/06/2023, via telephone, on 04/12/2023, via email and followed up with a recall notification letter on 05/05/2023. Customer was instructed to return affected product. |
|---|
| Quantity in Commerce | 5 units |
|---|
| Distribution | Distribution in the US to Georgia |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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